Manager, Corporate Regulatory Affairs

Job Description:

This role’s primary responsibility is to partner with Regulatory therapy area leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions. This Sr. Manager will coordinate activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants) to maintain up-to-date information on regulatory requirements and product submissions

Responsibilities:

Manages most aspects of company regulatory interface with domestic and international health authorities.

Manages the development and deployment of the regulatory program that ensures aggressive product approval.

Manages and may generate regulatory submission documents for new products or changes to existing health authorities' filings, including domestic and international submissions and registration.

Manages the submissions of clinical study submissions.

Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance.

Partners with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects.

Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations.

Determines international regulatory requirements and develops plans to comply with national laws in each country.